An observational study in Peritoneal Dialysis-associated Peritonitis, sponsored by CloudCath. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-30.
Sponsored by CloudCath · Observational
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care.
Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The notification capability of the CloudCath System will be deactivated for this study so that neither Study Participants nor Study Investigators will be aware of the device measurements.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's enrollment of 243 is above the median of 127 across 59 observational studies indexed under Peritonitis.
Browse Peritonitis studies →CloudCath is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients currently using home peritoneal dialysis.
Key Inclusion Criteria:
Key Exclusion Criteria:
Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis
Device: CloudCath Monitoring System
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.
Time of peritonitis detection (vs lab measures)
The time peritonitis is detected by the CloudCath System, as compared to time of laboratory evidence of peritonitis
Time frame: through 12 months
Time of peritonitis detection (vs clinical measures)
The time peritonitis is detected by the CloudCath System, as compared to time of peritonitis detection by standard clinical means (ISPD guidelines)
Time frame: through 12 months
Sensitivity and specificity of the CloudCath System detection of peritonitis
Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing
Time frame: through 12 months
Ability of study participants to use the CloudCath System as intended
Device performance measure; ability to use as intended
Time frame: through 12-months of study follow-up
Sensitivity and specificity of the CloudCath System detection of peritonitis and the resolution of peritonitis
Analysis of sensitivity and specificity of the detection of peritonitis and the detection of the resolution of peritonitis, as compared to diagnostic laboratory testing
Time frame: through 12 months
Sensitivity and specificity of the CloudCath System detection of resolution of peritonitis
Analysis of sensitivity and specificity of the resolution time of peritonitis
Time frame: through 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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